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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K210578
Device Name Medical Nitrile Examination Gloves (Power free, Blue)
Applicant
Jiangxi Hongda Medical Equipment Group , Ltd.
39 S. Shengli Rd. Jinxian County
Nanchang,  CN 331700
Applicant Contact Yang Qinghua
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/26/2021
Decision Date 07/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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